Stricture Definition and Treatment (STRIDENT) Endoscopic Therapy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

NCT03220841

Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel

UNKNOWN PHASE4

Stricture Definition and Treatment (STRIDENT) Observational Study.

NCT03218202

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis +1 more

TERMINATED

Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures

NCT06203782

Crohn Disease

RECRUITING NA

Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Strictures

NCT05521867

Crohn Disease

ACTIVE_NOT_RECRUITING NA

Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

NCT05009212

Crohn Disease Stricture; Bowel Endoscopy, Gastrointestinal

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective randomised controlled study. Patients with Crohn's Disease and symptomatic stricture(s) will undergo randomisation to receive standard or intensive endoscopic therapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard endoscopic therapy

Single endoscopic dilatation

Group Type ACTIVE_COMPARATOR

Standard (single) endoscopic stricture dilatation

Intervention Type PROCEDURE

single endoscopic stricture dilatation

Intensive endoscopic therapy

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Group Type EXPERIMENTAL

Intensive endoscopic stricture dilatation

Intervention Type PROCEDURE

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard (single) endoscopic stricture dilatation

single endoscopic stricture dilatation

Intervention Type PROCEDURE

Intensive endoscopic stricture dilatation

3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

Exclusion Criteria

* Acute bowel obstruction requiring urgent surgical intervention
* Deemed by treating physician to have high risk of acute bowel obstruction
* Concurrent active perianal sepsis
* Internal fistulising disease in association with strictures (entero-enteric stulas)
* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Pregnancy
* Inability to undergo MRI small bowel due to a contraindication.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No